About Hemophilia A

Living with Hemophilia A

Hemophilia is an inherited bleeding disorder caused by a deficiency of a coagulation factor, a protein in the blood that aids in the process of clotting. An effective clot is needed to seal wounds and stop bleeding.

Hemophilia A or "classic hemophilia" is the most common type of hemophilia, and is caused by a deficiency of clotting factor VIII (FVIII). Not having enough FVIII means that blood might not clot properly when there is bleeding, such as after an injury or during a dental procedure. Bleeding can also occur inside of a joint.

Symptoms of hemophilia A include:

  • Bruising easily
  • Bleeding in the mouth from a cut, bite, or tooth loss
  • Heavy nosebleeds for no apparent reason
  • Heavy bleeding from a minor cut
  • Cuts that resume bleeding after stopping for a short time

With few exceptions, hemophilia affects males, and hemophilia is classified as mild, moderate, or severe. Serious health consequences can arise if hemophilia is not treated promptly and properly.

Treating Hemophilia A

Hemophilia A treatment involves increasing the level of FVIII in the blood. This is done by infusing (injecting) factor replacement therapy, also called FVIII product.

There are two kinds of FVIII product:

  • Human plasma derived products are those that originate from human plasma. These products are manufactured using multiple safety processes, including careful screening of plasma donors and a very rigorous and stringent viral inactivation process.
  • Recombinant FVIII. The proteins needed to make FVIII product are not taken from human sources, but synthesized in a laboratory using recombinant DNA technology.

Some forms of recombinant FVIII still contain a protein from human blood called albumin*, which maybe used as a stabilizer. In 2000, sucrose replaced albumin as stabilizer in the production of the FVIII product Helixate®. With this change, Helixate® FS (formulated with sucrose) was born.

Helixate® FS is a generation factor product available for hemophilia A treatment.

*The baby hamster kidney cell line used to produce Helixate® FS is grown in a culture medium that contains human plasma protein. No human proteins are added during purification or in the final formulation

Next: Learn about The Helixate® FS Difference »

Important Safety Information

Helixate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Helixate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Helixate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

Please see the full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.